CN108653317B - Chitosan oligosaccharide oral solution and preparation method thereof - Google Patents
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- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
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Abstract
The invention provides a chitosan oligosaccharide oral liquid and a preparation method thereof. The chitosan oligosaccharide oral liquid comprises 25-40 parts of chitosan oligosaccharide, 1-3 parts of flavoring agent, 2-4 parts of preservative and 1.5-2 parts of stabilizer. The chitosan oligosaccharide oral liquid provided by the invention can obviously improve the stability of a chitosan oligosaccharide liquid preparation and improve the taste of chitosan oligosaccharide. The chitosan oligosaccharide oral liquid has good stability, ideal taste and obvious weight-losing effect.
Description
Technical Field
The invention belongs to the technical field of pharmacy, and particularly relates to a chitosan oligosaccharide oral solution and a preparation method thereof.
Background
Obesity is the most common metabolic imbalance disorder, and is becoming more prevalent throughout the world, not only in western societies, but also in developing countries as people become increasingly affluent. The obesity often induces hypertension, coronary arteriosclerotic heart disease, hyperlipidemia, fatty liver, cholecystitis, cholelithiasis, diabetes, glucose tolerance abnormality, pulmonary insufficiency, obesity and weakening of body resistance, so that immunologic function is reduced, blood rheology is abnormal, cerebral infarction, cerebral hemorrhage, myocardial infarction, respiratory diseases, arthritis deformans, varicose veins of lower limbs, amenorrhea and infertility of women and the like, thereby becoming a public health problem which is generally concerned all over the world.
Because obesity can cause serious health problems, prevention and treatment of obesity becomes an important subject of research in the medical community, and although the medical community generally considers that improving life style and reasonably eating and strengthening exercise are main measures for losing weight, the medical community also considers that the medical community can be the first choice for patients with excessive obesity who fail to achieve satisfactory control through reasonable diet and exercise treatment.
At present, many compound traditional Chinese medicine preparations are widely used, but the problems of unstable curative effect, unknown effective components, difficulty in international market sale and the like generally exist. Although various chemical weight-reducing drugs used clinically have a certain curative effect, most of them have certain side effects.
Chitosan oligosaccharide is also called as chito-oligosaccharide, is oligosaccharide formed by chitosan through breaking its main chain by physical, chemical or enzymatic degradation, and is the only basic amino-oligosaccharide containing positive charge in nature. The unique molecular structure of the poly-oligosaccharide enables the poly-oligosaccharide to have a plurality of biological activities, and the biological activities which are confirmed at present comprise the functions of reducing fat, enhancing immunity, resisting tumors, regulating blood fat, regulating blood pressure, accelerating the absorption of calcium and iron in vivo, reducing blood sugar, promoting the repair of joint tissues and the like. At present, chitosan oligosaccharide becomes an international emerging functional oligosaccharide.
Chitosan oligosaccharide is an ideal bioactive substance, has good water solubility and small molecular weight, is easy to absorb, utilize and degrade, but has strong hygroscopicity, so that the preparation is unstable. In the production process of the chitosan oligosaccharide, diluted acid is adopted to dissolve the chitosan, and then the chitosan oligosaccharide is degraded at the optimum temperature of the biological enzyme, so the chitosan oligosaccharide has a slight sour taste and bad taste.
Therefore, the development of a new chitosan oligosaccharide dosage form solves the technical problems of strong hygroscopicity, unstable preparation and poor taste of the chitosan oligosaccharide dosage form so as to fully exert the weight-losing efficacy, and has important significance.
Disclosure of Invention
The invention aims to provide a prescription process of a chitosan oligosaccharide oral liquid preparation, which can obviously improve the stability and the taste of a chitosan oligosaccharide liquid preparation, aiming at the technical problems of strong hygroscopicity, unstable preparation and poor taste of chitosan oligosaccharide in the prior art. The invention also provides a preparation method of the chitosan oligosaccharide oral liquid preparation.
The auxiliary materials and the process used in the invention are convenient and available, and are suitable for industrial production. The chitosan oligosaccharide oral liquid prepared by the invention has obvious weight-losing effect.
The invention is realized by the following technical scheme:
the oral liquid of the invention comprises the following components in parts by weight:
25-40 parts of chitosan oligosaccharide, 1-3 parts of flavoring agent, 2-4 parts of preservative and 1.5-2 parts of stabilizer.
The flavoring agent is one or more of maltol or sodium carboxymethylcellulose.
Maltol has bitter taste inhibiting, fishy smell removing and antiseptic effects, and is a broad-spectrum high-efficiency flavoring agent and sweetener. The glue substances such as sodium carboxymethyl cellulose can increase liquid viscosity and reduce diffusion of medicine in saliva to taste buds. The invention selects ethyl maltol and sodium carboxymethyl cellulose as flavoring agent.
Further, the flavoring agent is a mixture of ethyl maltol and sodium carboxymethyl cellulose, wherein the ratio of the ethyl maltol to the sodium carboxymethyl cellulose is 2: 1.
Further, the preservative is one or more of potassium sorbate and sodium benzoate.
Further, the stabilizer is one or more of xanthan gum, polyvinylpyrrolidone, sulfurous acid and gallic acid.
The invention also aims to provide a preparation method of the chitosan oligosaccharide oral liquid, and specifically, the preparation method of the oral liquid comprises the following steps: adding chitosan oligosaccharide, antiseptic and stabilizer into appropriate amount of purified water, shaking in constant temperature air bath until completely dissolving and clathrating, adding correctant, and adjusting pH to 7.3.
The inventor carries out the stability test of the chitosan oligosaccharide oral liquid, and the accelerated test and the long-term stability test investigation show that the chitosan oligosaccharide oral liquid has no obvious change in the aspects of properties, identification, pH value, relative density, loading difference, content measurement, microbial limit inspection and the like. The chitosan oligosaccharide oral liquid has stable quality.
The inventor also carries out a weight-losing effect experiment of the chitosan oligosaccharide oral liquid, and the experiment shows that the weight-losing effect of the chitosan oligosaccharide oral liquid is remarkable and equivalent to a positive drug effect, and the chitosan oligosaccharide oral liquid has high safety and small side effect when being used for losing weight.
Compared with the prior art, the invention has the following beneficial effects:
1. the invention can solve the problem of hygroscopicity of chitosan oligosaccharide raw materials, and the prepared chitosan oligosaccharide oral liquid is stable.
2. According to the invention, the original bad taste of the chitosan oligosaccharide oral liquid is covered by utilizing a special combined flavoring formula for the chitosan oligosaccharide, and the delicious taste is prepared.
3. The development of the chitosan oligosaccharide liquid preparation greatly improves the medication compliance of patients and increases the using population of the medicine.
4. The chitosan oligosaccharide liquid preparation solves the process bottleneck of the preparation of the medicament, is prepared by adopting the conventional liquid preparation process, has simple and convenient preparation method, easily obtained used auxiliary materials, economy and suitability for industrial production.
Detailed Description
The present invention is further illustrated by, but is not limited to, the following examples.
EXAMPLE 1 Chitosan oligosaccharide oral solution
Prescription:
| chitosan oligosaccharide | 25g |
| Ethyl maltol | 2g |
| Sodium carboxymethylcellulose | 1g |
| Potassium sorbate | 2g |
| Sodium benzoate | 0 |
| Xanthan gum | 0.5g |
| Polyvinyl pyrrolidone | 1g |
| Sulfurous acid | 0 |
| Gallic acid | 0 |
The preparation method comprises the following steps: adding chitosan oligosaccharide, antiseptic and stabilizer into appropriate amount of purified water, shaking in constant temperature air bath until completely dissolving and clathrating, adding correctant, and adjusting pH to 7.3.
EXAMPLE 2 Chitosan oligosaccharide oral solution
Prescription:
| chitosan oligosaccharide | 30g |
| Ethyl maltol | 2g |
| Sodium carboxymethylcellulose | 0 |
| Potassium sorbate | 0 |
| Sodium benzoate | 4g |
| Xanthan gum | 2g |
| Polyvinyl pyrrolidone | 0 |
| Sulfurous acid | 0 |
| Gallic acid | 0 |
The preparation method comprises the following steps: adding chitosan oligosaccharide, antiseptic and stabilizer into appropriate amount of purified water, shaking in constant temperature air bath until completely dissolving and clathrating, adding correctant, and adjusting pH to 7.3.
EXAMPLE 3 Chitosan oligosaccharide oral solution
Prescription:
the preparation method comprises the following steps: adding chitosan oligosaccharide, antiseptic and stabilizer into appropriate amount of purified water, shaking in constant temperature air bath until completely dissolving and clathrating, adding correctant, and adjusting pH to 7.3.
EXAMPLE 4 Chitosan oligosaccharide oral solution
Prescription:
| chitosan oligosaccharide | 32g |
| Ethyl maltol | 1g |
| Sodium carboxymethylcellulose | 1g |
| Potassium sorbate | 1g |
| Sodium benzoate | 2g |
| Xanthan gum | 0 |
| Polyvinyl pyrrolidone | 1.5g |
| Sulfurous acid | 0 |
| Gallic acid | 0.5g |
The preparation method comprises the following steps: adding chitosan oligosaccharide, antiseptic and stabilizer into appropriate amount of purified water, shaking in constant temperature air bath until completely dissolving and clathrating, adding correctant, and adjusting pH to 7.3.
EXAMPLE 5 Chitosan oligosaccharide oral solution
Prescription:
the preparation method comprises the following steps: adding chitosan oligosaccharide, antiseptic and stabilizer into appropriate amount of purified water, shaking in constant temperature air bath until completely dissolving and clathrating, adding correctant, and adjusting pH to 7.3.
Example 6 Chitosan oligosaccharide oral solution
Prescription:
| chitosan oligosaccharide | 26g |
| Ethyl maltol | 0 |
| Sodium carboxymethylcellulose | 3g |
| Potassium sorbate | 0 |
| Sodium benzoate | 3g |
| Xanthan gum | 0 |
| Polyvinyl pyrrolidone | 2g |
| Sulfurous acid | 0 |
| Gallic acid | 0 |
The preparation method comprises the following steps: adding chitosan oligosaccharide, antiseptic and stabilizer into appropriate amount of purified water, shaking in constant temperature air bath until completely dissolving and clathrating, adding correctant, and adjusting pH to 7.3.
Comparative example 1
| Chitosan oligosaccharide | 25g |
| Aspartame | 2g |
| Acesulfame potassium | 1g |
| Potassium sorbate | 2g |
| Sodium benzoate | 0 |
| Xanthan gum | 0.5g |
| Polyvinyl pyrrolidone | 1g |
| Sulfurous acid | 0 |
| Gallic acid | 0 |
The preparation method is the same as example 1.
Example 7 taste-modifying experiment of Chitosan oligosaccharide oral liquid preparation
The method comprises the following steps: the oral liquid is prepared according to different prescription proportions, 40 volunteers taste the oral liquid, all the prescriptions are scored, the taste is described, and the combination of the better prescription is obtained by counting the result.
And (3) fine grading: no smell is 0 point; negative taste such as bitter taste, bad smell and the like is given a negative score, and the range is-1 to-10; the delicious tastes such as sweet taste and fragrance are classified into 1-10. The results are shown in Table 1:
TABLE 1 taste-modifying experiment for liquid preparation of chitooligosaccharide
| Sweetness score | |
| Example 1 | 8.3±1.6 |
| Example 2 | 6.9±1.2 |
| Example 3 | 6.2±1.8 |
| Example 4 | 7.5±2.1 |
| Example 5 | 6.7±1.4 |
| Example 6 | 6.5±1.7 |
| Comparative example 1 | 3.2±1.4 |
The chitosan oligosaccharide oral liquid preparation can cover the sour taste of chitosan oligosaccharide, and has fresh and delicious taste. Particularly, the chitosan oligosaccharide oral liquid of the group 1 has the best mouthfeel, which indicates that the components and the mixture ratio of the prescription are optimal.
In the formula of the comparative example 1, although aspartame and acesulfame potassium have sweet mouthfeel, other strange flavors such as metal and plastic flavors are introduced, and the mouthfeel is not ideal.
Example 8 Chitosan oligosaccharide stability test of the invention
The inventor carries out the stability test of the chitosan oligosaccharide oral liquid, and compared with the chitosan oligosaccharide oral liquid of examples 1-6 in 6-month acceleration and 12-month long-term stability investigation, the evaluation item indexes have no obvious change in the aspects of character, identification, PH value, relative density, loading difference, content measurement, microorganism limit inspection and the like. The sample quality of the chitosan oligosaccharide oral liquid is stable.
Example 9 Experimental study on weight and lipid reduction of Chitosan oligosaccharide oral liquid
SD rats and males are randomly divided into a normal control group and a high-fat model group, the normal control group is fed with a common feed, the rest rats are fed with a high-fat feed (basal feed +30 lard), the rats are continuously fed for 4 months to induce obesity, the obese rats are divided into the obese model group, the orlistat group and each group of examples 1-6 according to the weight, the rats are subjected to intragastric administration according to the volume of 20ml/kg once a day for 14 days, the state of the rats is observed every day, and the weight of the rats is weighed every week.
The results are indicated in table 1: after 2 weeks of administration of the chitosan oligosaccharide oral liquid to obese rats, the weight of the rats was significantly reduced, and the difference compared with the model control group had statistical significance (P < 0.01). The chitosan oligosaccharide oral liquid has the advantages that the general condition of rats in various groups of the examples is good, the movement is free, the hair is smooth, and the adverse reactions such as listlessness, loose stool and the like of animals are not observed. The chitosan oligosaccharide oral liquid has good lipid-lowering effect and high safety.
TABLE 1 Effect of Chitosan oligosaccharide oral liquid on high fat diet induced obesity of rats
P <0.05, P <0.01 compared to model control.
Claims (2)
1. The chitosan oligosaccharide oral liquid is characterized by comprising the following raw and auxiliary materials in parts by weight:
25-40 parts of chitosan oligosaccharide, 1-3 parts of flavoring agent, 2-4 parts of preservative and 1.5-2 parts of stabilizer; the flavoring agent is a mixture of ethyl maltol and sodium carboxymethylcellulose, wherein the ratio of the ethyl maltol to the sodium carboxymethylcellulose is 2:1, the preservative is one or more of potassium sorbate and sodium benzoate, and the stabilizer is one or more of xanthan gum, polyvinylpyrrolidone, sulfurous acid and gallic acid.
2. The method for preparing the chitosan oligosaccharide oral liquid according to claim 1, comprising the steps of: adding chitosan oligosaccharide, antiseptic and stabilizer into appropriate amount of purified water, shaking in constant temperature air bath until completely dissolving and clathrating, adding correctant, and adjusting pH to 7.3.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810554058.9A CN108653317B (en) | 2018-06-01 | 2018-06-01 | Chitosan oligosaccharide oral solution and preparation method thereof |
| PCT/CN2018/103514 WO2019227747A1 (en) | 2018-06-01 | 2018-08-31 | Chitosan oligosaccharide oral solution and preparation method therefor |
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| CN201810554058.9A CN108653317B (en) | 2018-06-01 | 2018-06-01 | Chitosan oligosaccharide oral solution and preparation method thereof |
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| CN108653317B true CN108653317B (en) | 2021-04-06 |
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| CN111617030B (en) * | 2020-05-22 | 2021-09-07 | 广东药科大学 | Chitosan oligosaccharide oral liquid and application thereof in preparation of weight-reducing medicine |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1602891A (en) * | 2004-07-27 | 2005-04-06 | 张英伟 | Glucosidase oral liquid |
| CN106617024A (en) * | 2016-10-17 | 2017-05-10 | 广东省阳春市信德生物科技发展有限公司 | Formula for black garlic and chitosan oligosaccharide oral liquid and process for preparing same |
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| CN105533387A (en) * | 2015-12-09 | 2016-05-04 | 山东凯尔海洋生物科技有限公司 | Solid beverage containing inulin and chitosan oligosaccharide and preparation method thereof |
| CN106962613A (en) * | 2017-03-15 | 2017-07-21 | 成都合生元生物科技有限公司 | A kind of oligomerization sugar composite and preparation method thereof and feed |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1602891A (en) * | 2004-07-27 | 2005-04-06 | 张英伟 | Glucosidase oral liquid |
| CN106617024A (en) * | 2016-10-17 | 2017-05-10 | 广东省阳春市信德生物科技发展有限公司 | Formula for black garlic and chitosan oligosaccharide oral liquid and process for preparing same |
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| WO2019227747A1 (en) | 2019-12-05 |
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